Huons' 'Liztox' Approved for Phase 3 Clinical Trial to Treat Upper Limb Muscle Spasticity After Stroke
[Asia Economy Reporter Lee Chun-hee] Huons Biopharma's botulinum toxin 'Liztox' is advancing to Phase 3 clinical trials to expand its business into therapeutic areas.
Huons Biopharma, a subsidiary of Huons Global, announced on the 13th that it received approval from the Ministry of Food and Drug Safety for the domestic Phase 3 clinical trial plan (IND) of 'Liztox' (export name 'Hutox') for the treatment of post-stroke upper limb muscle spasticity.
Through this Phase 3 clinical trial, Huons Biopharma plans to confirm the efficacy and safety of Liztox in relieving muscle tone in adults diagnosed with post-stroke upper limb muscle spasticity. The clinical trial is expected to conclude and obtain indication approval by 2023. Upon approval, this will be Liztox's first therapeutic area indication.
Currently, Liztox's approved indications are limited to aesthetic uses such as glabellar lines and crow's feet improvement. To capture the rapidly growing therapeutic market, Huons Biopharma will conduct a Phase 2 clinical trial not only for post-stroke upper limb muscle spasticity but also for benign masseter hypertrophy. Additionally, to enhance Liztox's competitiveness in the therapeutic field, preparations have been completed to obtain approval for a high-dose 200-unit formulation, which is in high demand in this area. Unlike aesthetics, therapeutic applications generally require relatively larger doses, leading to a preference for high-dose products.
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Kim Young-mok, CEO of Huons Biopharma, stated, "Through last year's Phase 1 clinical trial, we secured valid data on the efficacy and safety of Liztox in alleviating post-stroke upper limb muscle spasticity," adding, "We will successfully complete Phase 3 trials and expand Liztox's influence across all areas, including aesthetics and therapeutics."
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